SPL Mapping FHIR Implementation Guide
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SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

Table of Contents

Page standards status: Informative
.. 0 Table of Contents
... 1 SPL Mapping Implementation Guide Home Page
... 2 Organziation-Based Use Cases
... 3 Submit a Drug Label
... 4 How to Create a FHIR Drug Label
... 5 SPL / FHIR Transforms
... 6 Downloads
... 7 Credits
... 8 Artifacts Summary
.... 8.1 Establishment Registration Logical Model
.... 8.2 GDUFA Facility Identification Logical Model
.... 8.3 NDC Labeler Code Request Logical Model
.... 8.4 Product Submission Document Logical Model
.... 8.5 Submitted Medication Logical Model
.... 8.6 EstablishmentInactivationBundle
.... 8.7 EstablishmentRegistrationBundle
.... 8.8 GDUFAFacilityIdentificationBundle
.... 8.9 GDUFAFacilityInactivationBundle
.... 8.10 LabelerCodeRequestBundle
.... 8.11 LabelerInactivationBundle
.... 8.12 OrganizationBundle
.... 8.13 OutOfBusinessBundle
.... 8.14 EstablishmentInactivationMessage
.... 8.15 EstablishmentRegistrationMessage
.... 8.16 GDUFAFacilityIdentificationMessage
.... 8.17 GDUFAFacilityInactivationMessage
.... 8.18 LabelerCodeRequestMessage
.... 8.19 LabelerInactivationMessage
.... 8.20 OrganizationMessage
.... 8.21 OutOfBusinessMessage
.... 8.22 IdentifiedLabeler
.... 8.23 LabelerBusinessOperation
.... 8.24 LabelerOrganization
.... 8.25 EstablishmentAffiliation
.... 8.26 EstablishmentBusinessOperation
.... 8.27 EstablishmentOrganization
.... 8.28 EstablishmentRegistrantOrganization
.... 8.29 IdentifiedEstablishment
.... 8.30 IdentifiedEstablishmentRegistrant
.... 8.31 GDUFAFacilityAffiliation
.... 8.32 GDUFAFacilityBusinessOperation
.... 8.33 GDUFAFacilityOrganization
.... 8.34 GDUFARegistrantOrganization
.... 8.35 IdentifiedGDUFAFacility
.... 8.36 IdentifiedGDUFARegistrant
.... 8.37 IdentifiedOrganization
.... 8.38 ImporterAffiliation
.... 8.39 ImporterOrganization
.... 8.40 RegistrantOrganization
.... 8.41 SPLAddress
.... 8.42 SPLContactPoint
.... 8.43 USAgentAffiliation
.... 8.44 USAgentOrganization
.... 8.45 Manufactured Item Marketing Status Date Range
.... 8.46 Packaged Product Reference
.... 8.47 ProductSubmissionBundle
.... 8.48 ProductSubmissionDocument
.... 8.49 SectionEffectiveTime
.... 8.50 SectionLinkId
.... 8.51 SubmittedIngredientDefinition
.... 8.52 SubmittedManufacturedItem
.... 8.53 SubmittedMedicinalPackaging
.... 8.54 SubmittedMedicinalProduct
.... 8.55 SubmittedMedicinalProductIngredient
.... 8.56 SubmittedMedicinalProductMarketing
.... 8.57 VersionNumber
.... 8.58 DualSubmissionProvenance
.... 8.59 SPLDocumentDate
.... 8.60 SPLDocumentReference
.... 8.61 AidarexPharmaceuticals
.... 8.62 Allopurinol100Tablets
.... 8.63 Allopurinol30Tablets
.... 8.64 Allopurinol60Tablets
.... 8.65 Allopurinol90Tablets
.... 8.66 Allopurinol<br/>Tablets USP<br/>Revised: February 2015<br/>Rx only        <br/>
.... 8.67 AllopurinolIngredientDefinition
.... 8.68 AllopurinolMarketing
.... 8.69 AllopurinolTablet
.... 8.70 AllopurinolTabletLabelBundle
.... 8.71 AllopurinolUSPActiveIngredient
.... 8.72 AllopurinolUSPDefinition
.... 8.73 AllopurinolUSPIngredient1
.... 8.74 AllopurinolUSPIngredient2
.... 8.75 AllopurinolUSPIngredient3
.... 8.76 AllopurinolUSPIngredient4
.... 8.77 AllopurinolUSPIngredient5
.... 8.78 AllopurinolUSPIngredient6
.... 8.79 Enbrel010Definition
.... 8.80 Enbrel010Marketing
.... 8.81 Enbrel010Package
.... 8.82 Enbrel021Definition
.... 8.83 Enbrel021Marketing
.... 8.84 Enbrel021Package
.... 8.85 Enbrel032Definition
.... 8.86 Enbrel032Marketing
.... 8.87 Enbrel032Package
.... 8.88 Enbrel044Definition
.... 8.89 Enbrel044Marketing
.... 8.90 Enbrel044Package
.... 8.91 Enbrel055Definition
.... 8.92 Enbrel055Marketing
.... 8.93 Enbrel055Package
.... 8.94 Enbrel25mgSolution
.... 8.95 Enbrel25mgSolutionActiveIngredient
.... 8.96 Enbrel25mgSolutionIngredient1
.... 8.97 Enbrel25mgSolutionIngredient2
.... 8.98 Enbrel25mgSolutionIngredient3
.... 8.99 Enbrel425Definition
.... 8.100 Enbrel425Marketing
.... 8.101 Enbrel425Package
.... 8.102 Enbrel425Part1Definition
.... 8.103 Enbrel425Part1Marketing
.... 8.104 Enbrel425Part1Package
.... 8.105 Enbrel425Part2Definition
.... 8.106 Enbrel425Part2Marketing
.... 8.107 Enbrel425Part2Package
.... 8.108 Enbrel435Definition
.... 8.109 Enbrel435Marketing
.... 8.110 Enbrel435Package
.... 8.111 Enbrel445Definition
.... 8.112 Enbrel445Marketing
.... 8.113 Enbrel445Package
.... 8.114 Enbrel446Definition
.... 8.115 Enbrel446Marketing
.... 8.116 Enbrel446Package
.... 8.117 Enbrel455Definition
.... 8.118 Enbrel455Marketing
.... 8.119 Enbrel455Package
.... 8.120 Enbrel456Definition
.... 8.121 Enbrel456Marketing
.... 8.122 Enbrel456Package
.... 8.123 Enbrel50mgSolution
.... 8.124 Enbrel50mgSolutionActiveIngredient
.... 8.125 Enbrel50mgSolutionIngredient1
.... 8.126 Enbrel50mgSolutionIngredient2
.... 8.127 Enbrel50mgSolutionIngredient3
.... 8.128 EnbrelIngredientDefinition
.... 8.129 EnbrelPowder
.... 8.130 EnbrelPowderActiveIngredient
.... 8.131 EnbrelPowderIngredient1
.... 8.132 EnbrelPowderIngredient2
.... 8.133 EnbrelPowderIngredient3
.... 8.134 EnbrelSterileSolution
.... 8.135 EnbrelSterileSolutionIngredient1
.... 8.136 EnbrelSterileSolutionIngredient2
.... 8.137 EnbrelSyringeLabelBundle
.... 8.138 ImmunexCorporation
.... 8.139 These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. <br/> <br/>ENBREL<sup>®</sup> (etanercept) injection, for subcutaneous use <br/>ENBREL<sup>®</sup> (etanercept) for injection, for subcutaneous use <br/>Initial U.S. Approval: 1998
.... 8.140 LantusActiveIngredient
.... 8.141 LantusIngredient1
.... 8.142 LantusIngredient2
.... 8.143 LantusIngredient3
.... 8.144 LantusIngredient4
.... 8.145 LantusIngredient5
.... 8.146 LantusIngredient6
.... 8.147 LantusIngredient7
.... 8.148 LantusIngredientDefinition
.... 8.149 LantusInjectionLabelBundle
.... 8.150 LantusSolution
.... 8.151 LantusSyringeDefinition
.... 8.152 LantusSyringeMarketing
.... 8.153 LantusSyringePackage
.... 8.154 LantusVialDefinition
.... 8.155 LantusVialMarketing
.... 8.156 LantusVialPackage
.... 8.157 SanofiAventisDeutschland
.... 8.158 SanofiAventisSRL
.... 8.159 SanofiAventisUS
.... 8.160 These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/> <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000
.... 8.161 ProvenanceActivitySearchParameter
.... 8.162 All NDC Products
.... 8.163 Business Operation Qualifiers
.... 8.164 Establishment Business Operations
.... 8.165 GDUFA Facility Business Operation Qualifiers
.... 8.166 GDUFA Facility Business Operations
.... 8.167 Generic Facility Message Types
.... 8.168 Labeler Business Operations
.... 8.169 Organzation Submission Message Types
.... 8.170 Registrant Organization Types
.... 8.171 SPL Document Codes
.... 8.172 SPL Marketing Statuses ValueSet
.... 8.173 SPL Product Characteristic Types ValueSet
.... 8.174 SPL Section Codes
.... 8.175 Top-Level Organization Types
.... 8.176 FHIR Specific SPL Message Types
.... 8.177 Medicinal Product Name Types CodeSystem
.... 8.178 Organization Relationship Types
.... 8.179 SPL Marketing Statuses CodeSystem
.... 8.180 SPL Organization Types
.... 8.181 SPL Product Characteristic Types CodeSystem
.... 8.182 EnbrelKit
.... 8.183 ExampleEstablishment
.... 8.184 ExampleEstablishmentAffiliation
.... 8.185 ExampleEstablishmentFHIRtoSPLProvenance
.... 8.186 ExampleEstablishmentOperation
.... 8.187 ExampleEstablishmentRegistrant
.... 8.188 ExampleEstablishmentRegistration
.... 8.189 ExampleEstablishmentSPLtoFHIRProvenance
.... 8.190 ExampleGDUFAFacility
.... 8.191 ExampleGDUFAFacilityAffiliation
.... 8.192 ExampleGDUFAFacilityIdentification
.... 8.193 ExampleGDUFAFacilityInactivation
.... 8.194 ExampleGDUFAFacilityOperation
.... 8.195 ExampleGDUFARegistrant
.... 8.196 ExampleImporter
.... 8.197 ExampleImporterAffiliation
.... 8.198 ExampleLabelerFHIRtoSPLProvenance
.... 8.199 ExampleLabelerSPLtoFHIRProvenance
.... 8.200 ExampleSPLDocumentReference
.... 8.201 IdentifiedLabelerOrganization
.... 8.202 SampleEstablishmentInactivationBundle
.... 8.203 SampleEstablishmentInactivationMessage
.... 8.204 SampleEstablishmentRegistrationMessage
.... 8.205 SampleGDUFAFacilityIdentificationMessage
.... 8.206 SampleGDUFAFacilityInactivationMessage
.... 8.207 SampleIdentifiedEstablishment
.... 8.208 SampleIdentifiedEstablishmentRegistrant
.... 8.209 SampleIdentifiedGDUFAFacility
.... 8.210 SampleIdentifiedGDUFARegistrant
.... 8.211 SampleLabelerBusinessOperation
.... 8.212 SampleLabelerCodeRequestBundle
.... 8.213 SampleLabelerCodeRequestMessage
.... 8.214 SampleLabelerInactivationBundle
.... 8.215 SampleLabelerInactivationMessage
.... 8.216 SampleLabelerOrganization
.... 8.217 SampleLabelerUSAgent
.... 8.218 SampleLabelerUSAgentAffiliation
.... 8.219 SampleOutOfBusinessNotificationBundle
.... 8.220 SamplOutOfBusinessMessage